Glaxo Defends Alli Safety Record

Sep 14, 2009 | Parker Waichman LLP

Last month we wrote that the U.S. Food & Drug Administration (FDA) was conducting a safety review of orlistat, the popular weight-loss drug sold over-the-counter as Alli, and its prescription version, Xenical. According to the agency, Xenical and Alli have been associated with dozens of reports of liver injuries. Now, Alli maker, GlaxoSmithKline, is struggling to improve its image following dropping sales as a result of the investigation.

According to the Associated Press (AP), Alli sales plummeted by 10 percent after the FDA announced its investigation late last month despite that, according to the drug maker, Alli is "the most widely studied weight loss medicine ever, with over 100 clinical studies involving 30,000 patients," according to a quote from Howard Marsh, chief medical officer of Glaxo's consumer products division, reported the AP. Analysts sited the drug’s difficult and embarrassing side effects, said the AP, such as anal leakage.

Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

Xenical, which is made by Roche, was approved in 1999. Alli, a lower-dose version of the drug that is made by GlaxoSmithKline, was approved for over-the-counter sales last year. Alli became enormously popular as soon as it hit stores, generating sales of $131 million in its first full year on the market. Unlike other weight loss remedies, neither Alli nor Xenical work by suppressing the appetite or increasing metabolism. Instead, orlistat prevents the digestive system from absorbing dietary fat, thereby reducing daily calorie intake. Both Alli and Xenical are meant to be used in conjunction with a low-fat diet.

According to an FDA Early Communication in August, between 1999 and October 2008, 32 reports of serious liver injury, including six cases of liver failure, in patients using a version of orlistat were submitted to the FDA’s Adverse Event Reporting System. Two cases involved Alli, said the FDA, according to the AP.

The agency said 30 of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.

The FDA requested that Glaxo provide information on the drug’s liver toxicity over a year ago; however, officials at the drug maker claim they received no advance notice of last month’s announcement by the FDA, reported the AP. "I think it's fair to say we would have liked to have had some advance notice of this, because we were forced into a position where we had to respond very quickly," said Roger Scarlett Smith, president of Glaxo's Pittsburgh-based consumer product division, quoted the AP.

According to FDA spokeswoman, Siobhan Delancey, the agency does not provide such early warnings, said the AP. "Many of these actions have the potential to significantly affect stock prices, and to provide advance warning may give certain investors an unfair advantage," said Delancey in a statement, quoted by the AP. Such notices were implemented by the agency in 2007 in response to complaints of its slow reactions to Merck’s, now banned, Vioxx, which was linked to serious cardiac events following its approval, said the AP.

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